Thrombus Aspiration in STEMI Patients With High Thrombus Burden
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Interventions
- Procedure: Thrombus aspirationProcedure: PCI Alone
- Registration Number
- NCT04212494
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included. Patients are randomized to be treated with or without manual thrombus aspiration(TA) during primary percutaneous coronary intervention(PPCI) by a ratio of 1:1.
- Detailed Description
This study is intended to explore the efficacy of thrombus aspiration (TA) in ST-Segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden who received primary PCI within 12 hours after the onset of symptoms, reducing the incidence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization within 180 days or stroke in 30 days.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3838
- Age ≥ 18 years;
- STEMI patients undergoing primary PCI within 12 hours after the onset of symptoms;
- High thrombus burden after guidewire passes the lesion (TIMI thrombus grade ≥3);
- Informed consent must be voluntary;
- Haemodynamic instability or cardiogenic shock;
- After thrombolytic therapy;
- The predicted survival time is less than 6 months due to non-cardiac disease;
- History of coronary artery bypass grafting;
- Participate in other researches within 30 days;
- Preoperative gastrointestinal bleeding or contraindications to dual antiplatelet therapy;
- Patients were considered unsuitable by other researchers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thrombus aspiration Thrombus aspiration Upfront manual thrombus aspiration followed by PCI PCI Alone PCI Alone PCI without upfront manual thrombus aspiration
- Primary Outcome Measures
Name Time Method Major adverse cardiovascular events up to180 days The first occurrence of cardiovascular death, recurrent myocardial infarction, stent thrombosis or target vessel revascularization
- Secondary Outcome Measures
Name Time Method Stroke up to 30 days The symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular
Composite adverse cardiocerebrovascular events up to 1 year The first occurence of cardiovascular death, recurrent myocardial infarction, stent thrombosis, target vessel revascularization or stroke.
Trial Locations
- Locations (50)
Kaiping Central Hospital
🇨🇳Kaiping, Guangdong, China
Huadu District People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Shenzhen Bao'an District People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
Fujian Provincial Hospital
🇨🇳Fuzhou, Fujian, China
The Second People's Hospital of Nanhai District
🇨🇳Foshan, Guangdong, China
First People's Hospital of Shunde (Affiliated Hospital at Shunde, Southern Medical University)
🇨🇳Foshan, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Guangzhou General Hospital of Guangzhou Military Command
🇨🇳Guangzhou, Guangdong, China
The first Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial Hospital of traditional Chinese Medicine
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The Second Affiliated Hospital, Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Huizhou Third People's Hospital
🇨🇳Huizhou, Guangdong, China
Jiangmen Central Hospital
🇨🇳Jiangmen, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Huangpu Division of The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Maoming People's Hospital
🇨🇳Maoming, Guangdong, China
Nanxiong people's Hospital
🇨🇳Nanxiong, Guangdong, China
The Second Affiliated Hospital of Shantou university Medical College
🇨🇳Shantou, Guangdong, China
Yue Bei People's Hospital
🇨🇳Shaoguan, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
The Eighth Affiliated Hospital, Sun Yat-Sen University
🇨🇳Shenzhen, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Taishan people's Hospital
🇨🇳Taishan, Guangdong, China
People's Hospital of Yangjiang City
🇨🇳Yangjiang, Guangdong, China
Sihui people's Hospital
🇨🇳Zhaoqing, Guangdong, China
Zhongshan People's Hospital
🇨🇳Zhongshan, Guangdong, China
The Fifth Affiliated Hospital, Sun Yat-Sen University
🇨🇳Zhuhai, Guangdong, China
Zhuhai people's Hospital
🇨🇳Zhuhai, Guangdong, China
Guilin people's Hospital
🇨🇳Guilin, Guangxi, China
The Second Clinical College of Hainan Medical University
🇨🇳Haikou, Hainan, China
Hainan People's Hospital
🇨🇳Haikou, Hainan, China
Wuhan Asia Heart Hospital
🇨🇳Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
GanZhou Municopal Hospital
🇨🇳Ganzhou, Jiangxi, China
Shangyou Hospital
🇨🇳Ganzhou, Jiangxi, China
Affiliated Hospital, Weifang Medical University
🇨🇳Weifang, Shandong, China
The first Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
West China Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Kashgar first people's Hospital
🇨🇳Kashgar, Xinjiang, China
The First Affilicated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Yan'an Hospital of Kunming City
🇨🇳Kunming, Yunnan, China
Shaoxing people's Hospital
🇨🇳Shaoxing, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Guangzhou Panyu Central Hospital
🇨🇳Guangzhou, Guangdong, China